MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS; UNKNOWN

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Nausea (1970); Foreign Body In Patient (2687); Salivary Gland Problem (4484); Dry Mouth (4485)

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

She thinks she drank the water with cleanser not the water [accidental device ingestion] she got surprised in the morning and feel nauseous and have stomachache [nausea] she got surprised in the morning and feel nauseous and have stomachache [stomach pain] female consumer had flu symptom since yesterday, and still has it.[flu symptoms] and her mouth is dry and feel like having white saliva on the tongue.[dry mouth] and her mouth is dry and feel like having white saliva on the tongue.[saliva discoloration] case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a female patient who received denture cleanser (polident overnight denture cleanser tablets) tablet for product used for unknown indication.On an unknown date, the patient started polident overnight denture cleanser tablets at an unknown dose and frequency.On an unknown date, an unknown time after starting polident overnight denture cleanser tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant), nausea, stomach pain, flu symptoms, dry mouth and saliva discoloration.The action taken with polident overnight denture cleanser tablets was unknown.On an unknown date, the outcome of the accidental device ingestion, nausea, stomach pain, dry mouth and saliva discoloration were unknown and the outcome of the flu symptoms was not recovered/not resolved.It was unknown if the reporter considered the accidental device ingestion, nausea, stomach pain, flu symptoms, dry mouth and saliva discoloration to be related to polident overnight denture cleanser tablets.Additional details: adverse event information was received via call center representative on (b)(6) 2021 and it was stated that, "female consumer has been used denture long time, so she used the polident cleanser everyday.Usually she cleanse it in the toilet, but yesterday she put the cleanser in the water with denture next to the bed head.But she thinks she drank the water with cleanser not the water.She got surprised in the morning and feel nauseous and have stomachache.So she drank water about 1000cc.Didn't have meal yet.Female consumer usually goes and purchased the product from the pharmacy infront of it.Female consumer had flu symptom since yesterday, and still has it.And her mouth is dry and feel like having white saliva on the tongue.Female consumer said she doesn't know exact product name because she can't see the writing on the package clearly.So registered as 36 tabs.".

Manufacturer Narrative

Argus case: (b)(4).

Event Description

Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a female patient who received denture cleanser (polident overnight denture cleanser tablets) tablet for product used for unknown indication.On an unknown date, the patient started polident overnight denture cleanser tablets at an unknown dose and frequency.On an unknown date, an unknown time after starting polident overnight denture cleanser tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant), nausea, stomach pain, flu symptoms, dry mouth and saliva discoloration.The action taken with polident overnight denture cleanser tablets was unknown.On an unknown date, the outcome of the accidental device ingestion, nausea, stomach pain, dry mouth and saliva discoloration were unknown and the outcome of the flu symptoms was not recovered/not resolved.It was unknown if the reporter considered the accidental device ingestion, nausea, stomach pain, flu symptoms, dry mouth and saliva discoloration to be related to polident overnight denture cleanser tablets.Additional details: adverse event information was received via call center representative on (b)(6) 2021 and it was stated that, "female consumer has been used denture long time, so she used the polident cleanser everyday.Usually she cleanse it in the toilet, but yesterday she put the cleanser in the water with denture next to the bed head.But she thinks she drank the water with cleanser not the water.She got surprised in the morning and feel nauseous and have stomachache.So she drank water about 1000cc.Didn't have meal yet.Female consumer usually goes and purchased the product from the pharmacy infront of it.Female consumer had flu symptom since yesterday, and still has it.And her mouth is dry and feel like having white saliva on the tongue.Female consumer said she doesn't know exact product name becuase she can't see the writing on the package clearly.So registered as 36 tabs." case correction performed to the initially processed report received on 08 apr-2021 identified during external review which was notified on 07-may-2021.The device medwatch form was filled.

• Brand Name: POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS
• Type of Device: UNKNOWN
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• MDR Report Key: 11793339
• MDR Text Key: 260224149
• Report Number: 1020379-2021-00017
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other